Mixed Local for Sciatic Block

NCT ID: NCT06671028

Last Updated: 2024-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-07-01

Brief Summary

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Choice of local anesthetics is the major determinant of the characteristics of a peripheral nerve block. Short acting local anesthetics while provides faster onset suffer from shorter duration. On the other hand, long acting local anesthetics while provides long duration suffered from long onset time. The ideal local anesthetics should provide faster nerve block onset while providing reasonable duration to provide sustained postoperative analgesia. Mixing short and long acting local anesthetics for nerve blocks may appear to be the solution however previous published studies have demonstrated similar onset time to long acting local anesthetics and with reduced duration. Recently, the London Health Sciences Centre established an ambulatory surgical centre. Fast onset peripheral nerve block is desirable. Previous studies have not looked at popliteal sciatic block and anecdotally we feel addition of short acting local anesthetics appear to speed up onset. We are therefore interested in conducting a randomize trial to determine whether mixing short and long acting local anesthetics can speed up onset of surgical quality block.

Detailed Description

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Conditions

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Regional Anesthesia Local Anesthetic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ropivacaine

Popliteal block using Ropivacaine 100 mg in 20 mL

Group Type ACTIVE_COMPARATOR

Ropivacaine 0,5%

Intervention Type DRUG

Popliteal sciatic block using ropivacaine 0.5% 20 mL

Ropivacaine anmd Lidocaine

Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL

Group Type EXPERIMENTAL

Ropivacaine and Lidocaine

Intervention Type DRUG

Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL

Interventions

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Ropivacaine and Lidocaine

Popliteal sciatic block using Ropivacaine 100 mg and Lidocaine 100 mg in 20 mL

Intervention Type DRUG

Ropivacaine 0,5%

Popliteal sciatic block using ropivacaine 0.5% 20 mL

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients (≥18 years old)
* Scheduled for elective below-knee surgeries such as ankle arthroscopy, lower limb fracture fixation, toe surgeries, etc
* Capable of providing informed consent

Exclusion Criteria

* History of allergic reaction to local anesthetics
* Pre-existing neurological disorders affecting lower limbs
* Significant renal or hepatic impairment
* Pregnancy or breastfeeding
* Less than 60kg
* Inability to provide informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role lead

Responsible Party

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Cheng Lin

Anesthesiologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Cheng Lin

Role: CONTACT

5196858500

References

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Bugamelli S, Zangheri E, Montebugnoli M, Borghi B, Ricci A, De Simone N, Bonfatti M, Elmar K, Luppi M, Pignotti E. One-day surgery for acquired forefoot deformity: sciatic nerve blockade with mepivacaine vs mepivacaine+ropivacaine: a prospective, randomized study. Minerva Anestesiol. 2007 Jan-Feb;73(1-2):57-64.

Reference Type BACKGROUND
PMID: 17356507 (View on PubMed)

Cuvillon P, Nouvellon E, Ripart J, Boyer JC, Dehour L, Mahamat A, L'hermite J, Boisson C, Vialles N, Lefrant JY, de La Coussaye JE. A comparison of the pharmacodynamics and pharmacokinetics of bupivacaine, ropivacaine (with epinephrine) and their equal volume mixtures with lidocaine used for femoral and sciatic nerve blocks: a double-blind randomized study. Anesth Analg. 2009 Feb;108(2):641-9. doi: 10.1213/ane.0b013e31819237f8.

Reference Type BACKGROUND
PMID: 19151302 (View on PubMed)

Valery P, Aliaksei M. A comparison of the onset time of complete blockade of the sciatic nerve in the application of ropivacaine and its equal volumes mixture with lidocaine: a double-blind randomized study. Korean J Anesthesiol. 2013 Jul;65(1):42-7. doi: 10.4097/kjae.2013.65.1.42. Epub 2013 Jul 19.

Reference Type BACKGROUND
PMID: 23904938 (View on PubMed)

Chen L, Wang Q, Shi K, Liu F, Liu L, Ni J, Fang X, Xu X. The effects of lidocaine used in sciatic nerve on the pharmacodynamics and pharmacokinetics of ropivacaine in sciatic nerve combined with lumbar plexus blockade: a double-blind, randomized study. Basic Clin Pharmacol Toxicol. 2013 Mar;112(3):203-8. doi: 10.1111/bcpt.12008. Epub 2012 Dec 6.

Reference Type BACKGROUND
PMID: 22985391 (View on PubMed)

Other Identifiers

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125572

Identifier Type: -

Identifier Source: org_study_id

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